Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202937
Company: ORBION PHARMS
Company: ORBION PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OLANZAPINE | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/02/2015 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/29/2021 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/29/2021 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/29/2021 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/29/2021 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
OLANZAPINE
TABLET, ORALLY DISINTEGRATING;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OLANZAPINE | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 091265 | APOTEX INC |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 203708 | AUROBINDO PHARMA LTD |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077243 | BARR LABS INC |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 203456 | CHARTWELL MOLECULAR |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 076534 | DR REDDYS LABS LTD |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 208146 | HEC PHARM |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 206892 | HISUN PHARM HANGZHOU |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 200221 | JUBILANT GENERICS |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 203044 | MACLEODS PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 202285 | MYLAN |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 202937 | ORBION PHARMS |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078109 | STRIDES PHARMA |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 090881 | SUN PHARM INDS |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 091415 | TORRENT |
| OLANZAPINE | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 202889 | ZYDUS PHARMS |
| ZYPREXA ZYDIS | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | Yes | AB | 021086 | LILLY |
TABLET, ORALLY DISINTEGRATING;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OLANZAPINE | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 091265 | APOTEX INC |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 203708 | AUROBINDO PHARMA LTD |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077243 | BARR LABS INC |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 203456 | CHARTWELL MOLECULAR |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 076534 | DR REDDYS LABS LTD |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 208146 | HEC PHARM |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 206892 | HISUN PHARM HANGZHOU |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 200221 | JUBILANT GENERICS |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 203044 | MACLEODS PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 202285 | MYLAN |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 202937 | ORBION PHARMS |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078109 | STRIDES PHARMA |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 090881 | SUN PHARM INDS |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 091415 | TORRENT |
| OLANZAPINE | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 202889 | ZYDUS PHARMS |
| ZYPREXA ZYDIS | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | Yes | AB | 021086 | LILLY |
TABLET, ORALLY DISINTEGRATING;ORAL; 15MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OLANZAPINE | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 091265 | APOTEX INC |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 203708 | AUROBINDO PHARMA LTD |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077243 | BARR LABS INC |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 203456 | CHARTWELL MOLECULAR |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 076534 | DR REDDYS LABS LTD |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 208146 | HEC PHARM |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 206892 | HISUN PHARM HANGZHOU |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 200221 | JUBILANT GENERICS |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 203044 | MACLEODS PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 202285 | MYLAN |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 202937 | ORBION PHARMS |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078109 | STRIDES PHARMA |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 090881 | SUN PHARM INDS |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 091415 | TORRENT |
| OLANZAPINE | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 202889 | ZYDUS PHARMS |
| ZYPREXA ZYDIS | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | Yes | AB | 021086 | LILLY |
TABLET, ORALLY DISINTEGRATING;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OLANZAPINE | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 091265 | APOTEX INC |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 203708 | AUROBINDO PHARMA LTD |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077243 | BARR LABS INC |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 203456 | CHARTWELL MOLECULAR |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 076534 | DR REDDYS LABS LTD |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 208146 | HEC PHARM |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 206892 | HISUN PHARM HANGZHOU |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 200221 | JUBILANT GENERICS |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 203044 | MACLEODS PHARMS LTD |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 202285 | MYLAN |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 202937 | ORBION PHARMS |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078109 | STRIDES PHARMA |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 090881 | SUN PHARM INDS |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 091415 | TORRENT |
| OLANZAPINE | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 202889 | ZYDUS PHARMS |
| ZYPREXA ZYDIS | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | Yes | AB | 021086 | LILLY |